European Biopharmaceutical Review

Spring 2008

At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR

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BioFinance and Management

In Freedom to Operate, John Mackle and Clive Lawrence at Clarion Solicitors take us through the various stages of litigation management of intellectual property necessary for the biological and pharmaceutical industries, informing everyone respectively of their rights

The biotechnology industry is demanding more and more high-calibre talent, yet the number of well-qualified Twenty-First Century Recruits is diminishing. Pete Leddy of Invitrogen examines this conundrum and the impact it will undoubtedly have on business success for the next few years

BioBusiness Development

Fewer and fewer pharma-biotech deals are being clinched, whether it is due to geographic relocation or a trend in pharmaceutical restructuring plans, leading Xavier Pinardon, Rodolphe Renac and Carlos Meca at Alcimed to ask, Deal or No Deal?

The EU pharmaceutical market may have become increasingly streamlined in recent years, but debate remains over the speed at which it is changing, particularly as regards the post-approval process, claim Alain J Gilbert and Mark Larkin at Bionest Partners in Cornering the EU Market: the Need for Creative Strategies

Cultural Competency is key to the global success of any international biotechnology company, argue Robin Ng and Judy Yeh at Dynamic Consultants International. Adeptly understanding and communicating with diverse cultures can significantly influence the global perception of a corporation

Robin Bhattacherjee of CV Therapeutics Europe outlines the regulatory complications and the strategic advantages that await the increasing number of biopharmaceutical companies who aim to take A Peek into Europe

Collaborate to Innovate is the message Heather Fraser at the IBM Institute for Business Value aims to convey. Biopartnering, if executed efficiently, can reap generous rewards both in terms of business success and product innovation, transforming the way in which businesses conduct such deals

BioResearch and Innovation

The latest developments in highly technological software solutions could revolutionise biopharmaceutical research.Michael Willett of Bruker Corporation discusses the various methodologies and viable options available, in Mass Spectrometry for the Next Generation

Optimised Peptide APIs facilitate effective drug delivery, but there are disadvantages inherent in their use that should not be overlooked. Udo Haberl, Hans-Georg Frank and Marco Emgenbroich at AplaGen GmbH evaluate the pharmacokinetic and pharamacodynamic optimisation of peptide APIs

Nick Barnett of Ocean Optics considers the significance of Raman spectroscopy as a tool for measuring active pharmaceutical ingredients and excipients as well as wider chemical analysis, in Modular Solutions for Low Resolution Raman Spectroscopy

Discovery Technology

Monoclonal antibodies are the most rapidly-expanding aspect of the therapeutic market, yet remain extremely high in cost due to manufacturing expense. Richard Buick, Nicolas Camper and Chris Scott at Fusion Antibodies discuss the cell line development that aims to increase cell productivity in The Antibody Effect

Matthew Segall at the ADMET Division, BioFocus DPI puts forward the question affecting almost every biopharmaceutical company: Why is it Still Drug Discovery? He investigates why the research and development process for the pharmaceutical industry is both expensive and of long duration, resulting in many failed projects

BioDevelopment and Regulatory

When Oral Bioavailability Becomes a Problem, it is crucial that companies assess the need for reliable prediction of preclinical bioavailability as well as the other limiting factors affecting this issue, assert Florence Salmon, Miriam Verwei and Robert Havenaar of TNO

The methods available to determine drugs and metabolites through bioanalysis are many and varied. Emma Waite at Tepnel Research Products and Services assesses the challenges of validation in comparison to chromatographic assays, in Validating Immunoassays: Best Practice Principles

The US is upping its game in order to compete with the EU in bringing biosimilars to the patients who need them. Following a Similar Path, by Suzanne Sensabaugh at MDS Pharma Services, evaluates the FDA’s role in this regulatory drive

BioFormulation and Manufacturing

Certain natural products when used as drugs combine high specificity and low side effects. Attaching poly(ethylene glycol) chains further improves their efficacy by enhancing bioavailability and biodistribution, claims Thomas Bruckdorfer at IRIS Biotech, in Drug Delivery with PEGylation

Find Your Niche advises David Rhodes of the Health Protection Agency, he investigates the notable development of speciality biotechnology products, continuing despite demands from many shareholders for greater numbers of ‘blockbuster’ drugs

Bridging Vaccine Translational Research is crucial in order for manufacturing strategy to influence vaccine development as well as monoclonal antibodies. Crawford Brown and Roger Lias of Eden Biodesign Inc assess how policy can target the unique properties of vaccines

BioRegional

The Basque Country is an increasingly vibrant bioregion, with an expanding cluster of innovative life science companies. In , María Aguirre at BioBasque explores this new bioscience hub, and the opportunities it can offer

European biotechnology companies continue to be attracted to the Australian research industry, due to its rapid expansion and progress. Nicola Watkinson of the Australian Government surveys the development and industry growth in this region, in Australian Research Excellence

Berlin, Germany, December 12, 2017 / B3C newswire / -- BioGenes GmbH,
specializing in ELISA development and production and a global leader in
host cell protein (HCP) assay development, today announces the
establishment of a Scientific Advisory Board which includes the
following four renowned experts:More info >>

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>